20 results
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28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Indigo Aspiration System - Modified 110 Aspiration Tubing
FDA 510(k)
FDA Class 2
·Cardiovascular
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 16, 2022
INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
FDA 510(k)
FDA Class 2
·Dental
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 30, 2022
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 30, 2022
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022
BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code GIM·May 31, 2018
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 5, 2023
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 20, 2013
ENDURANT ILIAC STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 22, 2011
INTELECT MOBILE COMBO
FDA Adverse Event
Malfunction
·CHATTANOOGA GROUP·Product code IPF·September 29, 2008
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 5, 2022
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 29, 2022
PROCLEIX ULTRIO ELITE ASSY
FDA Adverse Event
Injury
·GRIFOLS DIAGNOSTIC SOLUTIONS INC.·Product code MZF·March 20, 2019
PROCLEIX ULTRIO ELITE ASSAY
FDA Adverse Event
Injury
·GRIFOLS DIAGNOSTIC SOLUTIONS INC.·Product code MZF·February 26, 2018